Ensuring Pharmaceutical Safety: Mass Spectrometry Approaches to Nitrosamine Analysis

Nitrosamines, a class of potent carcinogenic and mutagenic compounds, have been reportedly associated with food, cosmetics and pharmaceutical industry. Their detection in pharmaceutical products sparked global regulatory concern due to their ability to form unintended by-products during drug synthesis and formulation.

The contamination of common medications—including ranitidine, metformin and pioglitazone—prompted widespread investigations and recalls, underscoring the urgent need for robust detection and mitigation strategies. Identifying and eliminating these impurities demands ultra-sensitive analytical methodologies, particularly mass spectrometric techniques that offer unparalleled precision in trace-level detection.

Almac Sciences plays a critical role in ensuring pharmaceutical safety by developing and optimising LC-MS methodologies to monitor harmful nitrosamines and thus allowing purging strategies to be put in place. A case study of the development and validation of a LC-MS method for the limit test of nitrosamine is presented.